The following data is part of a premarket notification filed by Comfort Acrylics Co. with the FDA for Comfor-dent Denture Liner.
| Device ID | K910795 |
| 510k Number | K910795 |
| Device Name: | COMFOR-DENT DENTURE LINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | COMFORT ACRYLICS CO. 12716 NE 7TH PLACE Vancouver, WA 98684 |
| Contact | Sherman L Watson |
| Correspondent | Sherman L Watson COMFORT ACRYLICS CO. 12716 NE 7TH PLACE Vancouver, WA 98684 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-07-11 |